Used in scans for prostate cancer. NDA 219592, held by Telix Innovations. Gallium Ga-68 Gozetotide.
As of Nov 13, 2026, NDA 219592 (Gozellix), held by Telix Innovations, was first approved by FDA on Mar 20, 2025, with 0 approved supplements and 0 published complete response letters.
GOZELLIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy. With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| GozellixN/A · powder;intravenous | Gallium Ga-68 Gozetotide | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
